Sinuplasty instrument with deflectable guide rail

ABSTRACT

An apparatus includes a body, a first shaft, an actuation assembly, and a dilation catheter. The first shaft includes a malleable distal portion. The actuation assembly includes a second shaft and an actuator. The second shaft is coaxially positioned about the first shaft. The actuator is operable to selectively bend the malleable distal portion of the first shaft. The dilation catheter is coaxially interposed between the first shaft and the second shaft. The dilation catheter includes an expandable dilator. The dilation catheter is operable to translate along the malleable distal portion of the first shaft.

PRIORITY

This application claims priority to U.S. Provisional Pat. App. No.62/783,252, entitled “Sinuplasty Instrument with Deflectable GuideRail,” filed Dec. 21, 2018, the disclosure of which is incorporated byreference herein.

BACKGROUND

In some instances, it may be desirable to dilate an anatomicalpassageway in a patient. This may include dilation of ostia of paranasalsinuses (e.g., to treat sinusitis), dilation of the larynx, dilation ofthe Eustachian tube, dilation of other passageways within the ear, nose,or throat, etc. One method of dilating anatomical passageways includesusing a guidewire and catheter to position an inflatable balloon withinthe anatomical passageway, then inflating the balloon with a fluid(e.g., saline) to dilate the anatomical passageway. For instance, theexpandable balloon may be positioned within an ostium at a paranasalsinus and then be inflated, to thereby dilate the ostium by remodelingthe bone adjacent to the ostium, without requiring incision of themucosa or removal of any bone. The dilated ostium may then allow forimproved drainage from and ventilation of the affected paranasal sinus.A system that may be used to perform such procedures may be provided inaccordance with the teachings of U.S. Pub. No. 2011/0004057, entitled“Systems and Methods for Transnasal Dilation of Passageways in the Ear,Nose or Throat,” published Jan. 6, 2011, now abandoned, the disclosureof which is incorporated by reference herein. An example of such asystem is the Relieva® Spin Balloon Sinuplasty™ System by Acclarent,Inc. of Irvine, Calif.

In the context of Eustachian tube dilation, a dilation catheter or otherdilation instrument may be inserted into the Eustachian tube and then beinflated or otherwise expanded to thereby dilate the Eustachian tube.The dilated Eustachian tube may provide improved ventilation from thenasopharynx to the middle ear and further provide improved drainage fromthe middle ear to the nasopharynx. Methods and devices for dilating theEustachian tube are disclosed in U.S. Patent Pub. No. 2010/0274188,entitled “Method and System for Treating Target Tissue within the ET,”published on Oct. 28, 2010, now abandoned, the disclosure of which isincorporated by reference herein; and U.S. Patent Pub. No. 2013/0274715,entitled “Method and System for Eustachian Tube Dilation,” published onOct. 17, 2013, now abandoned, the disclosure of which is incorporated byreference herein. An example of such a system is the Aera® EustachianTube Balloon Dilation System by Acclarent, Inc. of Irvine, Calif.

While a variable direction view endoscope may be used to providevisualization within the anatomical passageway, it may also be desirableto provide additional visual confirmation of the proper positioning ofthe balloon before inflating the balloon. This may be done using anilluminating guidewire. Such a guidewire may be positioned within thetarget area and then illuminated, with light projecting from the distalend of the guidewire. This light may illuminate the adjacent tissue(e.g., hypodermis, subdermis, etc.) and thus be visible to the naked eyefrom outside the patient through transcutaneous illumination. Forinstance, when the distal end is positioned in the maxillary sinus, thelight may be visible through the patient's cheek. Using such externalvisualization to confirm the position of the guidewire, the balloon maythen be advanced distally along the guidewire into position at thedilation site. Such an illuminating guidewire may be provided inaccordance with the teachings of U.S. Pat. No. 9,155,492, entitled“Sinus Illumination Lightwire Device,” issued Oct. 13, 2015, thedisclosure of which is incorporated by reference herein. An example ofsuch an illuminating guidewire is the Relieva Luma Sentry® SinusIllumination System by Acclarent, Inc. of Irvine, Calif.

Balloon sinuplasty procedures may be performed using a dilation catheterthat is either slidably coupled with a guide catheter (e.g., such thatthe dilation catheter is positioned in the guide catheter); or with aguide rail (e.g., such that the dilation catheter is positioned aboutthe exterior of the guide rail). In either case, it may be beneficial tobend the guide to achieve a particular bend angle that will facilitateinsertion of the dilation catheter in a particular anatomical passagewayin the head of the patient. For instance, it may be beneficial for theguide to provide a substantially straight configuration to guide thedilation catheter into a sphenoid sinus ostium; a bend angle ofapproximately 55 degrees to guide the dilation catheter into aEustachian tube; a bend angle of approximately 70 degrees to guide thedilation catheter into a frontal recess; or a bend angle ofapproximately 110 degrees to guide the dilation catheter into amaxillary sinus ostium.

It may be desirable to facilitate bending of a guide in order to achievevarious bend angles, thereby facilitating guidance of a dilationcatheter into various different anatomical passageways in the head of apatient, including in procedures that will be performed only by a singleoperator. While several systems and methods have been made and used toposition a balloon of a dilation catheter in an anatomical passageway,it is believed that no one prior to the inventors has made or used theinvention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1A depicts a perspective view of an exemplary dilation instrument,with a guidewire and a dilation catheter each in respective proximalpositions;

FIG. 1B depicts a perspective view of the instrument of FIG. 1A, withthe guidewire in a distal position and the dilation catheter in theproximal position;

FIG. 1C depicts a perspective view of the instrument of FIG. 1A, withthe guidewire and the dilation catheter each in respective distalpositions, and with a dilator of the dilation catheter in a non-expandedstate;

FIG. 1D depicts a perspective view of the instrument of FIG. 1A, withthe guidewire and the dilation catheter each in respective distalpositions, and with a dilator of the dilation catheter in an expandedstate;

FIG. 2 depicts an exploded perspective view of a guide shaft assembly ofthe instrument of FIG. 1A;

FIG. 3A depicts a cross-sectional side view of a distal portion of aflexible shaft member of the guide shaft assembly of FIG. 2, with thedistal portion in a straight configuration;

FIG. 3B depicts a cross-sectional side view of the flexible shaft memberof FIG. 3A in a bent configuration;

FIG. 4 depicts a perspective view of an exemplary alternative dilationinstrument;

FIG. 5A depicts a side view of the dilation instrument of FIG. 4, with adeflection actuation assembly in a proximal position, and with a guideshaft in a straight configuration;

FIG. 5B depicts a side view of the dilation instrument of FIG. 4, withthe deflection actuation assembly in a distal position and in anon-actuated state, and with the guide shaft in the straightconfiguration;

FIG. 5C depicts a side view of the dilation instrument of FIG. 4, withthe deflection actuation assembly in the distal position and in anactuated state, and with the guide shaft being bent by the actuateddeflection actuation assembly;

FIG. 5D depicts a side view of the dilation instrument of FIG. 4, withthe deflection actuation assembly in the proximal position and the guideshaft left in the bent state of FIG. 5C;

FIG. 5E depicts a side view of the dilation instrument of FIG. 4, withthe deflection actuation assembly in the proximal position and the guideshaft left in the bent state of FIG. 5C, with a dilation catheteradvanced to a distal position along the bent guide shaft, and with adilator of the dilation catheter in a non-expanded state;

FIG. 5F depicts a side view of the dilation instrument of FIG. 4, withthe deflection actuation assembly in the proximal position and the guideshaft left in the bent state of FIG. 5C, with a dilation catheteradvanced to a distal position along the bent guide shaft, and with adilator of the dilation catheter in an expanded state;

FIG. 6A depicts a side view of another example of a dilation instrument,with shaft assembly in a straight configuration; and

FIG. 6B depicts a side view of the dilation instrument of FIG. 6A, withthe shaft assembly in a bent configuration.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. For example, while various. Accordingly,the drawings and descriptions should be regarded as illustrative innature and not restrictive.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handpiece assembly.Thus, an end effector is distal with respect to the more proximalhandpiece assembly. It will be further appreciated that, for convenienceand clarity, spatial terms such as “top” and “bottom” also are usedherein with respect to the clinician gripping the handpiece assembly.However, surgical instruments are used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

It is further understood that any one or more of the teachings,expressions, versions, examples, etc. described herein may be combinedwith any one or more of the other teachings, expressions, versions,examples, etc. that are described herein. The following-describedteachings, expressions, versions, examples, etc. should therefore not beviewed in isolation relative to each other. Various suitable ways inwhich the teachings herein may be combined will be readily apparent tothose of ordinary skill in the art in view of the teachings herein. Suchmodifications and variations are intended to be included within thescope of the claims.

I. Exemplary Dilation Instrument with External Deflectable Guide Shaft

FIGS. 1A-1D show an exemplary dilation instrument (10) that may be usedto dilate an ostium or other passageway associated with drainage of aparanasal sinus, a Eustachian tube, or some other anatomical passageway(e.g., within the ear, nose, or throat, etc.). As will be described ingreater detail below, dilation instrument (10) of the present exampleprovides adjustability that enables the operator to use dilationinstrument (10) in different scenarios, without requiring the operatorto switch between different instruments. For instance, dilationinstrument (10) may be used to dilate various different anatomicalpassageways (e.g., frontal sinus ostium, frontal recess, maxillary sinusostium, sphenoid sinus ostium, ethmoid sinus ostium, Eustachian tube,etc.) by making simple adjustments to structural features of theinstrument.

Dilation instrument (10) of this example includes a handle assembly(100), a guide shaft assembly (200) extending distally from handleassembly (100); a guidewire actuation assembly (300) slidably coupledwith handle assembly (100); and a dilation catheter actuation assembly(400) slidably coupled with handle assembly (100). A guidewire module(12) is coupled with a guidewire (302) of instrument (10) via aconnector (310). An inflation fluid source (14) and an irrigation fluidsource (16) are fluidly coupled with a dilation catheter (402) ofinstrument (10) via a connector (410). A suction source (18) is coupledwith a suction port (420) of instrument (100).

Handle assembly (100) is sized and configured to be grasped and operatedby a single hand of an operator. The operator may selectively operateguidewire actuation assembly (300) and dilation catheter actuationassembly (400) with the same single hand that grasps handle assembly(100). As shown in the transition from FIG. 1A to FIG. 1B, the operatormay advance guidewire actuation assembly (300) distally along handleassembly (100) to thereby advance guidewire (302) distally, such that adistal end (304) of guidewire (302) is positioned distal to the distalend of guide shaft assembly (200). As shown in the transition from FIG.1B to FIG. 1C, the operator may then advance dilation catheter actuationassembly (400) distally along handle assembly (100) to thereby advance adilation catheter (402) distally along guidewire (302), such that thedistal tip (404) of dilation catheter (402) is positioned distal to thedistal end of guide shaft assembly (200). With dilation catheter (402)advanced to a distal position, the operator may then inflate a dilator(406) of dilation catheter (402) to achieve an expanded state as shownin FIG. 1D, to thereby dilate an anatomical passageway in which dilator(406) is positioned. In the present example, dilation catheter (402) iscoaxially disposed within guide shaft assembly (200), and guidewire(302) is coaxially disposed within dilation catheter (402). In otherexamples, guide shaft assembly (200) may be coaxially disposed withindilation catheter (402), and guidewire (302) may be coaxially disposedwithin guide shaft assembly (200).

In some versions of dilation instrument (10), guidewire (302) mayinclude one or more optical fibers, and distal end (304) may beconfigured to emit visible light. In some such versions, guidewiremodule (12) includes a light source, and connector (310) is operable tocommunicate light from the light source of guidewire module (12) toguidewire (302). Illuminating versions of guidewire (302) may be used toprovide position confirmation through observation of transilluminationeffects. By way of example only, illuminating versions of guidewire(302) may be constructed and operable in accordance with at least someof the teachings of U.S. Pat. No. 9,155,492, entitled “SinusIllumination Lightwire Device,” issued Oct. 13, 2015, the disclosure ofwhich is incorporated by reference herein.

In addition to providing illumination, or as an alternative to providingillumination, guidewire (302) may provide position sensing capabilities.In some such versions, the distal end of guidewire (302) may include aposition sensor. By way of example only, such a guidewire (302) may beconstructed and operable in accordance with at least some of theteachings of U.S. Pub. No. 2018/0214216, entitled “Navigation Guidewirewith Interlocked Coils,” published Aug. 2, 2018; U.S. Pub. No.2019/0192177, entitled “Reusable Navigation Guidewire,” published Jun.27, 2019; and/or U.S. Pub. No. 2016/0008083, entitled “GuidewireNavigation for Sinuplasty,” published Jan. 14, 2016, the disclosures ofeach of these references being incorporated by reference herein. In somesuch versions, guidewire module (12) includes an image-guided surgery(IGS) navigation system, and connector (310) is operable to communicateposition-indicative signals from the position sensor of guidewire (302)to guidewire module (12). In other versions of dilation instrument (10),guidewire (302) may be omitted entirely.

A. Exemplary Guide Shaft Assembly and Associated Actuation Assemblies

As shown in FIGS. 2-3, guide shaft assembly (200) of the present exampleincludes a rigid shaft member (210), a flexible shaft member (230)arranged at the distal end of rigid shaft member (210), a push-pull wire(260), a cam barrel (270), and a deflection control knob (280). Shaftmembers (210, 230), cam barrel (270), and deflection control knob (280)are coaxially aligned with each other in this example, with push-pullwire (260) being laterally offset from the central longitudinal axisshared by shaft members (210, 230), cam barrel (270), and deflectioncontrol knob (280). Shaft assembly (200) is operable to guide guidewire(302) and dilation catheter (402) along an operator-selected exit anglerelative to the central longitudinal axis of guide shaft assembly (200).

In some versions, both shaft members (210, 230) are formed of a metallicmaterial, such as stainless steel and/or nitinol. In some such versions,shaft members (210, 230) (and at least some other portions of instrument(10)) may be reusable, with such reusable components being subject tocleaning and sterilization between uses on different patients. In someother versions, one or both of shaft members (210, 230) may be formed ofa polymeric material. In some such versions, shaft members (210, 230)may be treated as single-use-only components. Flexible shaft member(230) is secured to rigid shaft member (210) and is positioned distallyin relation to rigid shaft member (210). As best seen in FIGS. 3A-3B,flexible shaft member (230) includes a flex section (240) that is formedby a series of ribs (242), which are separated by a series of notches(244). Notches (244) are generally V-shaped, with a circular opening atthe vertex of each “V.” Notches (244) also include tab portions (224)that fit in corresponding sub-notches (226). The top of each “V”includes a set of stop features (222).

As shown in FIG. 3A, when flex section (240) is in a straightconfiguration, tab portions (224) are disposed in correspondingsub-notches (226) but are not fully seated in sub-notches (226). As alsoshown in FIG. 3A, when flex section (240) is in a straightconfiguration, stop features (222) are separated from each other. FIG.3B shows flex section (240) in a fully deflected (or “bent”)configuration. In this state, tab portions (224) are fully seated insub-notches (226) and stop features (222) are engaged with each other.During the transition between the states shown in FIGS. 3A-3B, tabportions (224) and sub-notches (226) may cooperate to ensure that flexsection (240) deflects (or “bends”) in a consistent fashion, withsufficient lateral stability; and that flex section (240) provides aconsistent and stable deflected or straight state.

By way of example only, flex section (240) may be formed through lasercutting or any other suitable manufacturing process. In some versions,flex section (240) is covered with a flexible wrap (not shown). Such aflexible wrap may prevent tissue and other structures from gettingsnagged or pinched in notches (244), without compromising theflexibility of flex section (240). A flexible wrap may also ensure thatsuction provided through guide shaft assembly (200) is focused at adistal end (202) thereof. Various suitable forms that flex section (240)may take will be apparent to those of ordinary skill in the art in viewof the teachings herein. By way of further example only, flex section(240) may be constructed and operable in accordance with at least someof the teachings of U.S. Pub. No. 2018/0311472, entitled “DeflectableGuide for Medical Instrument,” published Nov. 1, 2018, the disclosure ofwhich is incorporated by reference herein.

Push-pull wire (260) is disposed within shaft members (210, 230) and isoperable to provide controlled deflection (or “bending”) of flex section(240). As shown in FIGS. 3A-3B, a distal end (262) of push-pull wire(260) is secured to the distal end (232) of flexible shaft member (230),distal to flex section (240). Push-pull wire (260) is disposed near theopen tops of the “V” shapes of notches (244). Thus, when push-pull wire(260) is pulled proximally, flex section (240) transitions to adeflected configuration, as shown in FIG. 3B. When push-pull wire (260)is then pushed distally, flex section (240) will return toward astraight configuration. A proximal end (234) of push-pull wire (260),shown in FIG. 2, is secured to cam barrel (270) by a retention key (notshown). Proximal end (234) is threaded into one or more lateral openingsin a key recess of cam barrel (270); and then the key is inserted intothe key recess to retain proximal end (234) in the lateral openings.Translation of cam barrel (270) drives translation of push-pull wire(260), which in turn causes deflection or straightening of flex section(240) as described above.

Cam barrel (270) is movably coupled with rigid shaft member (210) suchthat cam barrel (270) is slidable longitudinally along rigid shaftmember (210); yet cam barrel (270) is prevented from rotating relativeto rigid shaft member (210). As shown in FIG. 2, a tab (212) projectslaterally and unitarily from a proximal portion of rigid shaft member(210); and is configured to be slidably received within a lateralchannel (272) of cam barrel (270). The fit between tab (212) and lateralchannel (272) allows cam barrel (270) to slide longitudinally alongrigid shaft member (210) while preventing cam barrel (270) from rotatingabout rigid shaft member (210). Other suitable structures may be used toachieve this relationship between rigid shaft member (210) and cambarrel (270).

A pair of laterally opposed pins (220), shown in FIG. 2, are configuredto be fixedly secured in corresponding openings of deflection controlknob (280), and are configured to be movably captured in an annularspace (214) defined between annular flanges (116, 118) formed at aproximal end of rigid shaft member (210). The relationship between pins(220) and flanges (216, 218) allows deflection control knob (280) torotate relative to rigid shaft member (210) while preventing deflectioncontrol knob (280) from translating relative to rigid shaft member(210). Other suitable structures may be used to achieve thisrelationship between rigid shaft member (210) and deflection controlknob (280).

As noted above, proximal end (264) of push-pull wire (260) is secured tocam barrel (270), such that push-pull wire (260) translates with cambarrel (270) relative to rigid shaft member (210) in response torotation of deflection control knob (280) relative to rigid shaft member(210). As also noted above, translation of push-pull wire (260) relativeto rigid shaft member (210) causes lateral deflection of flex section(240). The operator may thus selectively deflect flex section (240) byrotating deflection control knob (280) relative to rigid shaft member(210).

When deflection control knob (280) is provided in a first rotationalposition (e.g., a home position), flex section (240) assumes a straightconfiguration defining a zero-deflection angle (or “bend angle”)relative to the longitudinal axis of guide shaft assembly (200). In thisstraight configuration, shaft assembly (200) is suitably configured toguide guidewire (302) and dilation catheter (400) into a firstanatomical passageway, such as the sphenoid sinus ostium. Whendeflection control knob (280) is rotated to a second rotationalposition, flex section (240) may assume a first deflected (or “bent”)configuration defining a first deflection angle relative to thelongitudinal axis selected to facilitate access to a second anatomicalpassageway, such as the Eustachian tube. By way of example only, thisfirst deflection angle may be from approximately 50 degrees toapproximately 60 degrees, or more particularly at approximately 55degrees.

When deflection control knob (280) is further rotated to a thirdrotational position, flex section (240) may assume a second deflectedconfiguration defining a second deflection angle selected to facilitateaccess to a third anatomical passageway, such as the frontal recess orfrontal sinus ostium. By way of example only, this second deflectionangle may be from approximately 65 degrees to approximately 70 degrees,or more particularly at approximately 70 degrees. When deflectioncontrol knob (280) is further rotated to fourth rotational position,flex section (240) may assume a third deflected configuration defining athird deflection angle selected to facilitate access to a fourthanatomical passageway, such as the maxillary sinus ostium. By way ofexample only, this third deflection angle may be from approximately 105degrees to approximately 115 degrees, or more particularly atapproximately 110 degrees.

Cam barrel (270) may be configured to lock in place rotationally suchthat once the operator achieves a desired deflection angle for flexsection (240) using deflection control knob (280), flex section (240)may maintain the selected angle until the operator again rotates knob(280). Since guidewire (302) and dilation catheter (402) are slidablydisposed within shaft assembly (200), guidewire (302) and dilationcatheter (402) will exit the distal end of shaft assembly (200) atwhatever deflection angle the operator has selected. In view of theforegoing, an operator may readily achieve various exit angles forguidewire (302) and dilation catheter (402) by rotating deflectioncontrol knob (280) relative to rigid shaft member (210). The operatormay thus readily dilate various anatomical passageways without having toexchange instruments; and without having to replace pieces of instrument(10).

In addition to enabling deflection of shaft assembly (200) via flexsection (240) and deflection control knob (280), it may be furtherdesirable to enable rotation of shaft assembly (200) about itslongitudinal axis, to further facilitate access to various anatomicalpassageways of a patient. In that regard, instrument (10) of the presentexample further includes a shaft rotation control knob (290) provided onan upper side of handle assembly (100) and which is selectivelyrotatable to thereby rotate shaft assembly (200) relative to handleassembly (100). In the present version, shaft rotation control knob(290) is oriented such that its rotational axis is perpendicular to thelongitudinal axis of shaft assembly (200). In use, an operator mayrotate rotation control knob (290) in first and second directions tothereby effect rotation of shaft assembly (200) in corresponding firstand second directions about its longitudinal axis. Rotation control knob(290) is suitably positioned on handle assembly (100) such that theoperator may rotate knob (290) using the thumb of the same hand that isgrasping handle assembly (100).

The various components of dilation instrument (10), including thoseshown but not described in detail herein, may be configured and operablein accordance with the teachings of U.S. Pub. No. 2019/0015645, entitled“Adjustable Instrument for Dilation of Anatomical Passageway,” publishedJan. 17, 2019; and/or U.S. Pub. No. 2019/0015646, entitled “AdjustableInstrument for Dilation of Anatomical Passageway,” published Jan. 17,2019, the disclosures of these references being incorporated byreference herein. Other variations of the features and functionalitiesdescribed herein will be apparent to those skilled in the art in view ofthe teachings herein.

II. Exemplary Dilation Instrument with Internal Deflectable Guide Shaft

In some instances, an operator may wish to use an internal guide rail orshaft to guide a dilation catheter like dilation catheter (402); insteadof using an external guide catheter or shaft like shaft assembly (200)to guide a dilation catheter like dilation catheter (402). In someinstruments, an internal guide or shaft may be used as a probe or seekerdevice in a way that an external guide could not be used. An example ofan instrument with an internal guide is described in U.S. Pat. No.10,137,286, entitled “Apparatus for Bending Malleable Guide of SurgicalInstrument,” issued Nov. 27, 2018, the disclosure of which isincorporated by reference herein. While the instrument described in thatreference includes an internal guide that can be used as a seeker andalso as a guide for a translating guide catheter, the instrumentrequires the use of an additional, separate device in order to bend theinternal guide to achieve a preferred guide angle. This may require theuse of at least one additional hand in order to accomplish the guidebending procedure. Moreover, this would require the instrument to becompletely removed from the patient in order to accomplish the guidebending procedure, followed by re-insertion of the instrument into thepatient.

In view of the foregoing, it may be desirable to provide a variation ofdilation instrument (10) that provides the enhanced functionalityassociated with an internal guide like the guide disclosed in U.S. Pat.No. 10,137,286; while enabling the operator to achieve the same kind ofselective bending of the guide in a manner similar to that providedthrough dilation instrument (10). The following describes merelyillustrative examples dilation instruments (110, 900) that provide theadvantages of an internal guide and the advantages of facilitatedcontrol over bending of the guide.

A. Dilation Instrument with Translating Deflection Actuation Assembly

As shown in FIGS. 4-5F, dilation instrument (110) of the present exampleincludes a handle assembly (500) defining main body for dilationinstrument (110) and a shaft assembly (120) distally extending from adistal end of handle assembly (500). Shaft assembly (120) includes amalleable guide shaft (840), which includes a rigid portion (844)positioned nearest handle assembly (500), and a guide rail region (842)at the distal end guide shaft (840). Guide rail region (842) includes amalleable portion (846), which is distal to proximal rigid portion(844), and a rigid portion (848) that is distal to malleable portion(846). Handle assembly (500) also includes a grip portion (530) tofacilitate grasping and control of dilation instrument (110) and relatedfunctions. Grip portion (50) may be selectively removable from dilationinstrument (110) in some versions.

Dilation instrument (110) further includes a deflection actuationassembly (800) that is positioned distally in relation to grip portion(530) and that is operable to selectively deflect guide rail region(842) of guide shaft (840) laterally relative to the longitudinal axisof shaft assembly (120). Deflection actuation assembly (800) isconfigured to translate longitudinally, as a unit, along guide shaft(840). Deflection actuation assembly (800) of this example includes aproximal stationary knob (820), an adjacently positioned distal rotaryknob (810), and an outer shaft (830) projecting distally from knobs(820). Outer shaft (830) is coaxially and slidably disposed about theouter perimeter of the guide shaft (840). Outer shaft (830) and rigidproximal portion (844) of shaft assembly (120) may include interactingfeatures (e.g., key and keyway, mating hex features, etc.) allowing theouter shaft (830) to slide along the rigid proximal portion (844) whilepreventing the outer shaft (830) from rotating about the rigid proximalportion (844).

The distal portion of outer shaft (830) includes a deflectable region(832) that is driven by rotary knob (810). As described in greaterdetail below, when rotary knob (810) is actuated to drive deflectableregion (832) to a deflected state, the deflection of deflectable region(832) may drive guide rail region (842) of guide shaft (840) to adeflected state. Deflection actuation assembly (800) may incorporatefeatures similar to those described above with reference to FIGS. 2-3Bto cause the lateral deflection of deflectable region (832) relative tothe longitudinal axis of shaft assembly (120) in response to rotation ofrotary knob (810) relative to stationary knob (820). For instance, therotation of rotary knob (810) relative to stationary knob (820) aboutthe longitudinal axis defined by the guide shaft (840) may deflectdeflectable region (832) with applied tension through a push-pull wiresimilar to push-pull wire (260) described above.

When rotary knob (810) is released, this may release tension in thepush-pull wire, such that deflectable region (832) no longer applies abending force to guide rail region (842) of guide shaft (840) and iscapable of returning to a straight configuration. Therefore, when outershaft (830) is no longer experiencing tension from the push-pull wire,outer shaft (830) can be translated along guide shaft (840) withoutcausing deflection of guide rail region (842) either toward or away fromthe longitudinal axis. It should also be noted that guide shaft (840) isconfigured to remain deflected after deactivation of deflectionactuation assembly (800) when deflection actuation assembly (800) islocated at the distal position. While knobs (810, 820) are provided inthe present example, deflection actuation assembly (800) may use anyother kinds of actuators in addition to or in lieu of knobs (810, 820)to drive a push-pull wire or other actuation feature to controllablydeflect deflectable region of outer shaft (830). Various alternativestructures and configurations will be apparent to those skilled in theart in view of the teachings herein.

Directable region (832) may be configured to only bend when positionedover flexible region (846) of guide shaft (840) after deflectionactuation assembly (800) has been translated along the guide shaft(840). The alignment of directable region (832) and flexible region(846) may be simplified by causing the alignment to be made whendeflection actuation assembly (800) is fully translated distally fromthe handle assembly (500). The deflection of directable region (832) andflexible region (846) is contemplated to be in any direction away fromthe longitudinal axis in any direction needed during a procedure.

Dilation instrument (110) of the present example further includes adilation catheter slider (700) that slidably coupled with grip portion(530) and is operable to translate a dilation catheter (702). Dilationcatheter (702) is slidably disposed over guide shaft (840) and insidethe inner diameter of outer shaft (830). As dilation catheter (702)translates distally, dilation catheter (702) will follow the pathdefined by guide rail region (842) of guide shaft (840). The proximalend (730) of dilation catheter (702) may be coupled with any suitablefluid source or fluid sources, such as inflation fluid source (14) andan irrigation fluid source (16) described above. As shown in FIGS.5E-5F, the distal end of dilation catheter (702) includes an expandabledilator (722), which is in the form of a balloon in the present example.Dilator (722) is configured to expand when filled with fluid (e.g.,saline) from a fluid source that is coupled with proximal end (730) ofdilation catheter (702).

While not shown, some versions of dilation instrument (110) may comprisea guidewire (602) slidably disposed within the inner diameter of outershaft (830); or more particularly within an inner diameter of guideshaft (840). Dilation instrument (110) may also include a guidewireactuation assembly, similar to guidewire actuation assembly (300) ofinstrument (10), that is operable to translate the guidewire along alongitudinal axis and rotate the guidewire about the longitudinal axis.Some versions of dilation instrument (110) may also include a shaftrotation assembly (not shown) that is operable to rotate the entireshaft assembly (120) unitarily relative to handle assembly (500) about alongitudinal axis. Various suitable forms that such a shaft rotationassembly may take will be apparent to those skilled in the art in viewof the teachings herein.

FIGS. 5A-5F show an exemplary sequence of operation of dilationinstrument (110). As shown in FIG. 5A, dilation instrument (110) is in astate where dilation catheter slider (700), dilation catheter (702), anddeflection actuation assembly (800) are in proximal positions. In thisconfiguration, guide rail region (842) of guide shaft (840) is exposedrelative to the distal end of outer shaft (830) and is in a straightconfiguration. In some instances, guide rail region (842) may beinserted into a patient's head (e.g., via a nostril or via the mouth)when dilation instrument (110) is in the state shown in FIG. 5A.

As shown in FIG. 5B, deflection actuation assembly (800) has translateddistally along the longitudinal axis defined by guide shaft (840) overguide shaft (840), to a position where deflectable region (832) of outershaft (830) is longitudinally aligned over malleable distal portion(846) of guide shaft (840). As shown in FIG. 5C, rotary knob (810) ofdeflection actuation assembly (800) is rotated relative to stationaryknob (820), thereby bending deflectable region (832) of outer shaft(830) laterally away from the longitudinal axis. As outer shaft (830) isbent at deflectable region (832), malleable distal portion (846) is alsobent such that guide rail region (842) is deflected away from the axisby deflectable region (832).

While FIG. 5C shows deflectable region (832) and guide rail region (842)bent to an angle of approximately 90 degrees, it should be understoodthat deflection actuation assembly (800) may instead be actuated to bendguide rail region (842) at various other bend angles, including anglesgreater than 90 degrees and angles less than 90 degrees. The selectedbend angle may correspond with the particular anatomical passageway thatthe operator wishes to dilate with dilator (722), as is known in theart. It should also be understood that knobs (810, 820) may includedetents, visual indicia, and/or other features to provide feedback tothe operator, indicating the bend angle of deflectable region (832) andguide rail region (842) as the operator rotates rotary knob (810)relative to stationary knob (820).

Once the operator has achieved the desired bend angle in guide railregion (842), the operator may release rotary knob (810) and thentranslate deflection actuation assembly (800) back to the proximalposition as shown in FIG. 5D, leaving bent guide rail region (842)exposed. With the release of rotary knob (810), outer shaft (830) outershaft (830) to enters a relaxed stated where it is no longer forced tobe bent. As deflection actuation assembly (800) is retracted to theproximal position, outer shaft (830) eventually straightens out alongrigid portion (844) of guide shaft (840); while guide rail region (842)maintains the bent configuration due to the malleability of distalportion (846). As deflection actuation assembly (800) is retracted tothe proximal position and outer shaft (830) correspondingly straightensout, rotary knob (810) may rotate freely relative to stationary knob(820) to relieve tension in the push-pull wire or other actuator thathad driven deflectable region (832) to the bent state. It should benoted that any one or more of the steps depicted in FIGS. 5B-5D may becarried out before guide rail region (842) is disposed in the patient'shead or after guide rail region (842) has been positioned in thepatient's head. In any case, the operator may manipulate dilationinstrument to position the distal end of bent guide rail region (842) tothereby orient the distal end of bent guide rail region (842) toward theanatomical passageway (e.g., paranasal sinus ostium, frontal recess,Eustachian tube, etc.) that the operator wishes to dilate.

After the operator has achieved the desired bend angle in guide railregion (842) and retracted deflection actuation assembly (800) to exposeguide rail region (842), the operator may slide dilation catheter slider(700) distally along grip portion (530) to thereby drive dilationcatheter (702) distally along guide rail region (842), as shown in FIG.5E. Due to the malleability of distal portion (846) of guide shaft(840), guide rail region (842) fully maintains its bent configuration asdilation catheter (702) translates along guide rail region (842). Asdilation catheter (702) translates distally along guide rail region(842), dilator (722) eventually passes the distal end of guide railregion (842) and enters the targeted anatomical passageway. Dilator(722) remains in a non-expanded configuration until dilator (722) ispositioned within the targeted anatomical passageway. Once dilator (722)is positioned within the targeted anatomical passageway, fluid may becommunicated to dilator (722) via proximal end (730) of dilationcatheter (702), thereby expanding dilator (722) as shown in FIG. 5F. Inthe expanded state, dilator (722) may dilate the anatomical passagewayin which dilator (722) is disposed.

After dilator (722) has dilated the targeted anatomical passageway,fluid may be relieved or withdrawn from dilator (722) to return dilator(722) to the non-expanded configuration shown in FIG. 5E. The operatormay then retract dilation catheter slider (700) proximally along gripportion (530) to thereby drive dilation catheter (702) proximally to theposition shown in FIG. 5D. In some cases, dilation instrument (110) maysimply be removed from the head of the patient at this stage, even whileguide rail region (842) is in a bent state.

Alternatively, after dilator (722) has returned to the non-expandedconfiguration shown in FIG. 5E, the operator may drive deflectionactuation assembly (800) distally to the position shown in FIG. 5C, thenrotate rotary knob (810) relative to stationary knob (820). In some suchcases, the operator may wish to rotate rotary knob (810) relative tostationary knob (820) to drive deflectable region (832) of outer shaft(830) to a straight configuration, thereby driving guide rail region(842) to a straight configuration, before removing dilation instrument(110) from the head of the patient. In some other cases, the operatormay wish to rotate rotary knob (810) relative to stationary knob (820)to drive deflectable region (832) of outer shaft (830) to a second bentconfiguration, thereby driving guide rail region (842) to a second bentconfiguration. This second bent configuration may reorient guide railregion (842) to a second bend angle that is selected to facilitateaccess to a second anatomical structure in the head of the patient.After achieving this second bend angle, the above-described steps may berepeated to dilate the second anatomical structure. This process may berepeated as many times as desired, such that guide rail region (842) maybe bent two or more times to guide dilation catheter (702) into two ormore anatomical structures within the head of the patient, withoutneeding to remove dilation instrument (110) from the head of the patientbetween these dilations.

B. Dilation Instrument with Non-Translating Deflection ActuationAssembly

FIGS. 6A-6B show another dilation instrument (900) that is substantiallysimilar to dilation instrument (110) except for the differencesdescribed below. Dilation instrument (900) of this example includes ahandle assembly (910) with a grip portion (912) and a dilation catheterslider (914), just like grip portion (530) and dilation catheter slider(700) described above. Dilation instrument (900) further includes ashaft assembly (920) and a deflection actuation assembly (930).

Shaft assembly (920) includes an outer shaft (940) and an inner shaft(950). In the present example, shafts (940, 950) are longitudinallyfixed relative to each other, such that outer shaft (940) does notlongitudinally translate relative to inner shaft (950). Outer shaft(940) includes a flexible section (942) that is operationally coupledwith deflection actuation assembly (930).

Deflection actuation assembly (930) includes a first knob (932) and asecond knob (934). Second knob (934) is rotatable relative to first knob(932) to transition flexible section (942) between a straightconfiguration (FIG. 6A) and a bent configuration (FIG. 6B). By way ofexample only, deflection actuation assembly (930) may be coupled withflexible section (942) or the distal end (944) of outer shaft (940) viaone or more pull-wires. In such versions, rotation of second knob (934)relative to first knob (932) may pull such one or more pull-wires, whichmay in turn drive lateral deflection of flexible section (942) anddistal end (944) from the straight configuration shown in FIG. 6A to abent configuration like what is shown in FIG. 6B. In some such versions,flexible section (942) is resiliently biased to return to the straightconfiguration, such that outer shaft (940) will return to the straightconfiguration when tension is relieved in the one or more pull-wireswhen second knob (934) is rotated in the opposite direction relative tofirst knob (932). Alternatively, the one or more pull-wires may havesufficient column strength to push, such that the one or more pull-wiresmay actively drive outer shaft (940) to return to the straightconfiguration when second knob (934) is rotated in the oppositedirection relative to first knob (932). In such versions, flexiblesection (942) may simply be passively flexible rather than beingresiliently biased toward the straight configuration. As yet anothermerely illustrative variation, flexible section (942) may be malleablesuch that flexible section (942) will maintain a bend angle that isapplied by deflection actuation assembly (930); while also allowingdeflection actuation assembly (930) to drive flexible section (942) backto the straight configuration.

Inner shaft (950) may be configured and operable like malleable guideshaft (840) described above. Inner shaft (950) of this example includesa rigid distal portion (952) that protrudes distally relative to distalend (944) of outer shaft (940). Inner shaft (950) also includes aflexible portion (not shown) that is longitudinally positioned withinflexible section (942) of outer shaft (940). In some versions, thisflexible portion of inner shaft (950) is malleable, such that themalleability of the flexible portion of inner shaft (950) will maintainthe bend angle formed in the flexible portion of inner shaft (950). Suchmalleability of the flexible portion of inner shaft (950) may providesufficient strength to resist a resilient bias of flexible section (942)of outer shaft (940) to return to the straight configuration in versionswhere flexible section (942) of outer shaft (940) is resiliently biasedto return to the straight configuration. In versions where flexiblesection (942) of outer shaft (940) is not resiliently biased to returnto the straight configuration, a malleable flexible portion of innershaft (950) may still be driven by deflection actuation assembly (930)return to a straight configuration after being driven to a bentconfiguration. In some other variations, the flexible portion of innershaft (950) is passively flexible rather than being malleable. In suchversions, a malleable version of flexible section (942) of outer shaft(940) may provide the support to maintain a bend angle as shown in FIG.6B. Alternatively, the flexible portion of inner shaft (950) andflexible section (942) of outer shaft (940) may both be passivelyflexible; and deflection actuation assembly (930) may include one ormore features to maintain a bend angle as shown in FIG. 6B. By way ofexample only, deflection actuation assembly (930) may includeself-locking threading, detent features, locking features, or any othersuitable kinds of features as will be apparent to those skilled in theart in view of the teachings herein.

In the present example, the dilation catheter (not shown) of dilationinstrument (900) is radially interposed between the inner diameter ofouter shaft (940) and the outer diameter of inner shaft (950). Thedilation catheter of dilation instrument (900) is thus positionedsimilar to dilation catheter (702) of dilation instrument (110). Alsolike dilation catheter (702) of dilation instrument (110), the dilationcatheter of dilation instrument (900) is coupled with dilation catheterslider (914), such that dilation catheter slider (914) may be advanceddistally relative to grip portion (912) to thereby drive the dilationcatheter distally relative to outer shaft (940) and inner shaft (950).Dilation instrument (900) may thus achieve operational states similar tothe operational states of dilation instrument (110) shown in FIGS.5E-5F. In some other variations, the dilation catheter of dilationinstrument (900) is slidably disposed about the exterior of outer shaft(940) and inner shaft (950). In such versions, the dilation catheter ofdilation instrument (900) is not positioned within the interior of outershaft (940). In versions where the dilation catheter of dilationinstrument (900) is slidably disposed about the exterior of outer shaft(940) and inner shaft (950), dilation catheter slider (914) may still beused to advance the dilation catheter distally in the manner describedabove; and the dilation catheter may still be used to dilate a paranasalsinus ostium, Eustachian tube, or other passageway in a patient's ear,nose, or throat as described above.

III. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

EXAMPLE 1

An apparatus, comprising: (a) a body; (b) a first shaft extendingdistally relative to the body, wherein the first shaft includes amalleable distal portion; (c) an actuation assembly, wherein theactuation assembly includes: (i) second shaft extending distallyrelative to the body, wherein the second shaft is coaxially positionedabout the first shaft, and (ii) an actuator, wherein the actuator isoperable to selectively bend the malleable distal portion of the firstshaft; and (d) a dilation catheter coaxially interposed between thefirst shaft and the second shaft, wherein the dilation catheter includesan expandable dilator, wherein the dilation catheter is operable totranslate along the malleable distal portion of the first shaft.

EXAMPLE 2

The apparatus of Example 1, wherein the first shaft includes a rigidproximal portion.

EXAMPLE 3

The apparatus of any one or more of Examples 1 through 2, wherein thesecond shaft includes a deflectable distal portion, wherein thedeflectable distal portion is operable to bend the malleable distalportion of the first shaft in response to actuation of the actuator.

EXAMPLE 4

The apparatus of Example 3, wherein the actuation assembly is operableto translate along the first shaft between a proximal position and adistal position, wherein the deflectable distal portion of the secondshaft is configured to be positioned proximal to the malleable distalportion of the first shaft when the actuation assembly is in theproximal position, wherein the deflectable distal portion of the secondshaft is configured to be positioned about the malleable distal portionof the first shaft when the actuation assembly is in the distalposition.

EXAMPLE 5

The apparatus of any one or more of Examples 1 through 4, wherein theactuator is positioned at a proximal end of the second shaft.

EXAMPLE 6

The apparatus of Example 5, wherein the actuator is positioned distal tothe body.

EXAMPLE 7

The apparatus of any one or more of Examples 1 through 6, wherein theactuation assembly is operable to translate relative to the body alongthe first shaft.

EXAMPLE 8

The apparatus of any one or more of Examples 1 through 7, wherein theactuator comprises a first member and a second member, wherein the firstmember is rotatable relative to the second member to selectively bendthe malleable distal portion of the first shaft.

EXAMPLE 9

The apparatus of Example 8, wherein the first member comprises a rotaryknob rotatable relative to the second shaft, wherein the second membercomprises a stationary knob fixedly secured relative to the secondshaft.

EXAMPLE 10

The apparatus of any one or more of Examples 8 through 9, wherein theactuator further comprises a translating member, wherein the translatingmember is configured to translate and thereby selectively bend themalleable distal portion of the first shaft in response to rotation ofthe first member relative to the second member.

EXAMPLE 11

The apparatus of Example 10, wherein the translating member comprises awire.

EXAMPLE 12

The apparatus of any one or more of Examples 1 through 11, wherein firstshaft and the actuation assembly include features configured to preventrotation of the second shaft relative to the first shaft.

EXAMPLE 13

The apparatus of any one or more of Examples 1 through 12, furthercomprising a slider slidably coupled with the body, wherein the slideris operable to drive the dilation catheter longitudinally along thefirst shaft.

EXAMPLE 14

The apparatus of any one or more of Examples 1 through 13, wherein thedilator in a non-expanded state is configured to fit in an anatomicalpassageway in a human head, wherein the dilator in an expanded state isconfigured to dilate the anatomical passageway.

EXAMPLE 15

The apparatus of any one or more of Examples 1 through 14, wherein thedilation catheter is operable to translate between a proximal positionand a distal position, wherein the dilator is configured to bepositioned distal to a distal end of the first shaft when the dilationcatheter is in the distal position.

EXAMPLE 16

The apparatus of Example 15, wherein the dilator is configured to bepositioned proximal to a distal end of the second shaft when thedilation catheter is in the proximal position.

EXAMPLE 17

An apparatus, comprising: (a) a body; (b) a shaft assembly extendingdistally relative to the body, wherein the shaft assembly comprises: (i)a first shaft, wherein the first shaft includes a malleable distalportion, and (ii) a second shaft, wherein the second shaft is coaxiallypositioned about the first shaft, wherein the second shaft includes adeflectable portion; (c) an actuator, wherein the actuator is operableto selectively drive the deflectable portion to bend the malleabledistal portion of the first shaft; and (d) a dilation catheter coaxiallyinterposed between the first shaft and the second shaft, wherein thedilation catheter includes an expandable dilator, wherein the dilationcatheter is operable to translate along the malleable distal portion ofthe first shaft.

EXAMPLE 18

The apparatus of Example 17, wherein the actuator is secured to aproximal portion of the second shaft.

EXAMPLE 19

A method comprising: (a) advancing an outer shaft of a dilationinstrument distally along an inner shaft of the dilation instrument tothereby position a deflectable portion of the outer shaft along amalleable portion of the inner shaft; (b) actuating an actuator of thedilation instrument to drive the deflectable portion of the outer shaftto bend the malleable portion of the inner shaft laterally; and (c)retracting the outer shaft proximally relative to the inner shaft,wherein the malleable portion of the inner shaft remains bent after theouter shaft is retracted proximally.

EXAMPLE 20

The method of Example 19, further comprising advancing a dilationcatheter distally along the inner shaft, wherein the dilation catheteris coaxially interposed between the inner shaft and the outer shaft,wherein the dilation catheter is advanced distally along the malleableportion of the inner shaft, wherein the malleable portion of the innershaft remains bent as the dilation catheter is advanced distally alongthe malleable portion of the inner shaft.

IV. Miscellaneous

It should be understood that any of the examples described herein mayinclude various other features in addition to or in lieu of thosedescribed above. By way of example only, any of the examples describedherein may also include one or more of the various features disclosed inany of the various references that are incorporated by reference herein.

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Versions may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, versions of the device may be disassembled, and any numberof the particular pieces or parts of the device may be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a surgical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various versions of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, versions, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

I/We claim:
 1. An apparatus, comprising: (a) a body; (b) a first shaftextending distally relative to the body, wherein the first shaftincludes a malleable distal portion; (c) an actuation assembly, whereinthe actuation assembly includes: (i) second shaft extending distallyrelative to the body, wherein the second shaft is coaxially positionedabout the first shaft, and (ii) an actuator, wherein the actuator isoperable to selectively bend the malleable distal portion of the firstshaft; and (d) a dilation catheter coaxially interposed between thefirst shaft and the second shaft, wherein the dilation catheter includesan expandable dilator, wherein the dilation catheter is operable totranslate along the malleable distal portion of the first shaft.
 2. Theapparatus of claim 1, wherein the first shaft includes a rigid proximalportion.
 3. The apparatus of claim 1, wherein the second shaft includesa deflectable distal portion, wherein the deflectable distal portion isoperable to bend the malleable distal portion of the first shaft inresponse to actuation of the actuator.
 4. The apparatus of claim 3,wherein the actuation assembly is operable to translate along the firstshaft between a proximal position and a distal position, wherein thedeflectable distal portion of the second shaft is configured to bepositioned proximal to the malleable distal portion of the first shaftwhen the actuation assembly is in the proximal position, wherein thedeflectable distal portion of the second shaft is configured to bepositioned about the malleable distal portion of the first shaft whenthe actuation assembly is in the distal position.
 5. The apparatus ofclaim 1, wherein the actuator is positioned at a proximal end of thesecond shaft.
 6. The apparatus of claim 5, wherein the actuator ispositioned distal to the body.
 7. The apparatus of claim 1, wherein theactuation assembly is operable to translate relative to the body alongthe first shaft.
 8. The apparatus of claim 1, wherein the actuatorcomprises a first member and a second member, wherein the first memberis rotatable relative to the second member to selectively bend themalleable distal portion of the first shaft.
 9. The apparatus of claim8, wherein the first member comprises a rotary knob rotatable relativeto the second shaft, wherein the second member comprises a stationaryknob fixedly secured relative to the second shaft.
 10. The apparatus ofclaim 8, wherein the actuator further comprises a translating member,wherein the translating member is configured to translate and therebyselectively bend the malleable distal portion of the first shaft inresponse to rotation of the first member relative to the second member.11. The apparatus of claim 10, wherein the translating member comprisesa wire.
 12. The apparatus of claim 1, wherein first shaft and theactuation assembly include features configured to prevent rotation ofthe second shaft relative to the first shaft.
 13. The apparatus of claim1, further comprising a slider slidably coupled with the body, whereinthe slider is operable to drive the dilation catheter longitudinallyalong the first shaft.
 14. The apparatus of claim 1, wherein the dilatorin a non-expanded state is configured to fit in an anatomical passagewayin a human head, wherein the dilator in an expanded state is configuredto dilate the anatomical passageway.
 15. The apparatus of claim 1,wherein the dilation catheter is operable to translate between aproximal position and a distal position, wherein the dilator isconfigured to be positioned distal to a distal end of the first shaftwhen the dilation catheter is in the distal position.
 16. The apparatusof claim 15, wherein the dilator is configured to be positioned proximalto a distal end of the second shaft when the dilation catheter is in theproximal position.
 17. An apparatus, comprising: (a) a body; (b) a shaftassembly extending distally relative to the body, wherein the shaftassembly comprises: (i) a first shaft, wherein the first shaft includesa malleable distal portion, and (ii) a second shaft, wherein the secondshaft is coaxially positioned about the first shaft, wherein the secondshaft includes a deflectable portion; (c) an actuator, wherein theactuator is operable to selectively drive the deflectable portion tobend the malleable distal portion of the first shaft; and (d) a dilationcatheter coaxially interposed between the first shaft and the secondshaft, wherein the dilation catheter includes an expandable dilator,wherein the dilation catheter is operable to translate along themalleable distal portion of the first shaft.
 18. The apparatus of claim17, wherein the actuator is secured to a proximal portion of the secondshaft.
 19. A method comprising: (a) advancing an outer shaft of adilation instrument distally along an inner shaft of the dilationinstrument to thereby position a deflectable portion of the outer shaftalong a malleable portion of the inner shaft; (b) actuating an actuatorof the dilation instrument to drive the deflectable portion of the outershaft to bend the malleable portion of the inner shaft laterally; and(c) retracting the outer shaft proximally relative to the inner shaft,wherein the malleable portion of the inner shaft remains bent after theouter shaft is retracted proximally.
 20. The method of claim 19, furthercomprising advancing a dilation catheter distally along the inner shaft,wherein the dilation catheter is coaxially interposed between the innershaft and the outer shaft, wherein the dilation catheter is advanceddistally along the malleable portion of the inner shaft, wherein themalleable portion of the inner shaft remains bent as the dilationcatheter is advanced distally along the malleable portion of the innershaft.